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    SEC Form 10-Q filed by Enveric Biosciences Inc.

    5/14/25 4:59:36 PM ET
    $ENVB
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $ENVB alert in real time by email
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    UNITED STATES

    SECURITIES AND EXCHANGE COMMISSION

    Washington, D.C. 20549

     

    FORM 10-Q

     

    ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

     

    For the quarterly period ended: March 31, 2025

     

    OR

     

    ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

     

    For the transition period from ___ to ___

     

    Commission File Number 001-38286

     

    ENVERIC BIOSCIENCES, INC.

    (Exact name of registrant as specified in its charter)

     

    Delaware   95-4484725

    (State or other jurisdiction of

    incorporation or organization)

     

    (IRS Employer

    Identification No.)

     

    4851 Tamiami Trail N, Suite 200

    Naples, FL

      34103
    (Address of principal executive offices)   (Zip code)

     

    (239) 302-1707
    (Registrant’s telephone number, including area code)

     

    Securities registered pursuant to Section 12(b) of the Act:

     

    Title of Each Class   Trading Symbol(s)   Name of each exchange on which registered
    Common Stock, $0.01 par value per share   ENVB   The Nasdaq Stock Market LLC

     

    Securities registered pursuant to Section 12(g) of the Act: None

     

    Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

     

    Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

     

    Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:

     

      Large accelerated filer ☐ Accelerated filer ☐
      Non-accelerated filer ☒ Smaller reporting company ☒
        Emerging growth company ☐

     

    If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

     

    If the securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

     

    Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

     

    As of May 14, 2025, the Registrant had 2,471,656 shares of Common Stock (par value $0.01 per share) outstanding.

     

     

     

     

     

     

    ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

     

    FORM 10-Q

     

    TABLE OF CONTENTS

     

        Page
      PART I - FINANCIAL INFORMATION  
    Item 1. Financial Statements  
      Condensed Consolidated Balance Sheets as of March 31, 2025 (Unaudited) and December 31, 2024 2
      Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31, 2025 and 2024 3
      Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the three months ended March 31, 2025 and 2024 4
      Unaudited Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2025 and 2024 6
      Notes to Unaudited Condensed Consolidated Financial Statements 7
    Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 14
    Item 3. Quantitative and Qualitative Disclosures About Market Risk 19
    Item 4. Controls and Procedures 19
         
      PART II - OTHER INFORMATION  
    Item 1. Legal Proceedings 20
    Item 1A. Risk Factors 20
    Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 20
    Item 3. Defaults Upon Senior Securities 20
    Item 4. Mine Safety Disclosures 20
    Item 5. Other Information 20
    Item 6. Exhibits 20

     

     

     

     

    ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED BALANCE SHEETS

     

       March 31, 2025   December 31, 2024 
       (Unaudited)     
    ASSETS          
    Current assets:          
    Cash  $4,294,435   $2,241,026 
    Prepaid expenses and other current assets   540,405    493,558 
    Total current assets   4,834,840    2,734,584 
               
    Other assets:          
    Property and equipment, net   267,279    305,777 
    Intangible assets, net   —    42,182 
    Total other assets   267,279    347,959 
    Total assets  $5,102,119   $3,082,543 
               
    LIABILITIES, MEZZANINE EQUITY, AND SHAREHOLDERS’ EQUITY          
    Current liabilities:          
    Accounts payable  $669,194   $521,747 
    Due to related parties   101,375    232,891 
    Accrued expenses and other current liabilities   413,837    735,098 
    Total current liabilities   1,184,406    1,489,736 
               
    Commitments and contingencies (Note 9)   -    - 
               
    Mezzanine equity          
    Series C redeemable preferred stock, $0.01 par value, 100,000 shares authorized, and 0 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively   —    — 
    Total mezzanine equity   —    — 
               
    Shareholders’ equity          
    Preferred stock, $0.01 par value, 20,000,000 shares authorized; Series B preferred stock, $0.01 par value, 3,600,000 shares authorized, 0 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively   —    — 
    Common stock, $0.01 par value, 100,000,000 shares authorized, 2,471,656 and 678,002 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively   24,716    6,780 
    Additional paid-in capital   112,750,472    108,255,049 
    Accumulated deficit   (108,259,471)   (106,074,505)
    Accumulated other comprehensive loss   (598,004)   (594,517)
    Total shareholders’ equity   3,917,713    1,592,807 
    Total liabilities, mezzanine equity, and shareholders’ equity  $5,102,119   $3,082,543 

     

    See the accompanying notes to the unaudited condensed consolidated financial statements.

     

    2

     

     

    ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

     

       2025   2024 
       For the Three Months Ended March 31, 
       2025   2024 
    Operating expenses          
    General and administrative  $1,360,138   $1,885,753 
    Research and development   746,371    506,155 
    Depreciation and amortization   81,024    85,409 
    Total operating expenses   2,187,533    2,477,317 
               
    Loss from operations   (2,187,533)   (2,477,317)
               
    Other income          
    Other income   2,565    21,437 
    Interest income, net   2    696 
    Total other income   2,567    22,133 
               
    Net loss before income taxes   (2,184,966)   (2,455,184)
               
    Income tax expense   —    (1,731)
               
    Net loss   (2,184,966)   (2,456,915)
               
    Other comprehensive loss          
    Foreign currency translation   (3,487)   17,906 
               
    Comprehensive loss  $(2,188,453)  $(2,439,009)
               
    Net loss per share - basic and diluted  $(1.22)  $(9.21)
               
    Weighted average shares outstanding, basic and diluted   1,797,774    266,764 

     

    See the accompanying notes to the unaudited condensed consolidated financial statements.

     

    3

     

     

    ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY

     

       Shares   Amount   Capital   Deficit   Loss   Equity 
       FOR THE THREE MONTHS ENDED MARCH 31, 2025 
       Common Stock   Additional Paid-In   Accumulated   Accumulated Other Comprehensive   Total Shareholders’ 
       Shares   Amount   Capital   Deficit   Loss   Equity 
    Balance at January 1, 2025   678,002   $6,780   $108,255,049 - $(106,074,505)  $(594,517)  $1,592,807 
    Issuance of common stock and Series A and B and prefunded warrants for cash, net of offering costs of $755,487   1,229,330    12,293    4,232,174    —    —    4,244,467 
    Issuance of common shares for vested RSAs   14,586    146    (146)   —    —    — 
    Issuance of common shares for exercise of warrants   462,336    4,623    70,421    —    —    75,044 
    Issuance of round up shares   87,402    874    (874)-  —    —    — 
    Stock based compensation   —    —    193,848    —    —    193,848 
    Foreign exchange translation loss   —    —    —    —    (3,487)   (3,487)
    Net loss   —    —    —    (2,184,966)   —    (2,184,966)
    Balance at March 31, 2025   2,471,656   $24,716   $112,750,472 - $(108,259,471)  $(598,004)  $3,917,713 

     

    See the accompanying notes to the unaudited condensed consolidated financial statements.

     

    4

     

     

    ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY

     

       Shares   Amount   Capital   Receivable   Deficit   Loss   Equity 
       FOR THE THREE MONTHS ENDED MARCH 31, 2024 
       Common Stock   Additional Paid-In   Subscription   Accumulated   Accumulated Other Comprehensive   Total Shareholders’ 
       Shares   Amount   Capital   Receivable   Deficit   Loss   Equity 
    Balance at January 1, 2024   182,625    1,827    100,841,416   $(1,817,640)   (96,499,518)   (569,749)  $1,956,336 
    Balance   182,625    1,827    100,841,416   $(1,817,640)   (96,499,518)   (569,749)  $1,956,336 
    Common stock sold under the Equity Distribution Agreement, net of offering costs of $583,713   111,200    1,112    1,807,677    —    —    —    1,808,789 
    Issuance of direct offering shares   15,246    152    322,301    —    —    —    322,453 
    Exercise of Inducement Warrants for common stock   130,267    1,303    2,675,677    —    —    —    2,676,980 
    Proceeds from the subscription receivable related to the issuance of Inducement Warrants, net of offering costs of $12,821   —    —    (12,821)   280,500    —    —    267,679 
    Proceeds from the subscription receivable related to the exercise of warrants and preferred investment options and issuance of common stock in abeyance   46,934    469    (469)   1,537,140    —    —    1,537,140 
    Stock based compensation   —    —    351,488    —    —    —    351,488 
    Foreign exchange translation gain   —    —    —    —    —    17,906    17,906 
    Net loss   —    —    —    —    (2,456,915)   —    (2,456,915)
    Balance at March 31, 2024   486,272   $4,863   $105,985,269   $—   $(98,956,433)  $(551,843)  $6,481,856 
    Balance   486,272   $4,863   $105,985,269   $—   $(98,956,433)  $(551,843)  $6,481,856 

     

    See the accompanying notes to the unaudited condensed consolidated financial statements.

     

    5

     

     

    ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

     

       2025   2024 
       For the Three Months Ended March 31, 
       2025   2024 
    Cash Flows From Operating Activities:          
    Net loss  $(2,184,966)  $(2,456,915)
    Adjustments to reconcile net loss to cash used in operating activities          
    Change in fair value of warrant liability   (858)   (10,039)
    Change in fair value of investment option liability   (1,707)   (11,398)
    Stock-based compensation   193,848    351,488 
    Amortization of intangibles   42,182    42,188 
    Depreciation expense   38,842    43,221 
    Change in operating assets and liabilities:          
    Prepaid expenses and other current assets   (46,126)   (759,289)
    Accounts payable, accrued expenses and other current liabilities   (301,281)   202,397 
    Due to related parties   (131,516)   — 
    Net cash used in operating activities   (2,391,582)   (2,598,347)
               
    Cash Flows From Financing Activities:          
    Proceeds from sale of common stock and warrants, net of offering costs   4,373,870    — 
    Proceeds from the exercise of warrants   75,044    2,676,980 
    Proceeds from the subscription receivable related to the issuance of Inducement Warrants and the exercise of warrants and preferred investment options   —    1,817,640 
    Proceeds from common stock sold under the Equity Distribution Agreement, net of offering costs   —    2,307,707 
    Payment for offering costs previously accrued   —    (144,058)
    Net cash provided by financing activities   4,448,914    6,658,269 
               
    Effect of foreign exchange rate on changes on cash   (3,923)   8,137 
               
    Net increase in cash   2,053,409    4,068,059 
    Cash at beginning of period   2,241,026    2,287,977 
    Cash at end of period  $4,294,435   $6,356,036 
               
    Supplemental disclosure of cash flow transactions:          
    Cash paid for interest  $—   $— 
    Income taxes paid  $—   $24,001 
               
    Non-cash financing and investing activities:          
    Non-cash issuance of round-up shares  $874   $— 
    Non-cash issuance of RSA vested shares  $146   $— 
    Offering costs accrued not paid  $129,403   $49,249 
    Issuance of common shares for offering costs  $—   $322,453 

     

    See the accompanying notes to the unaudited condensed consolidated financial statements.

     

    6

     

     

    ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

    NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

     

    NOTE 1. BUSINESS AND LIQUIDITY AND OTHER UNCERTAINTIES

     

    Nature of Operations

     

    Enveric Biosciences, Inc. (“Enveric” or the “Company”) is a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, addiction, and other psychiatric disorders. The head office of the Company is located in Naples, Florida. The Company has the following wholly-owned subsidiaries: Jay Pharma Inc. (“Jay Pharma”), 1306432 B.C. Ltd., 1236567 B.C. Unlimited Liability Company, MagicMed Industries, Inc. (“MagicMed”), Enveric Biosciences Canada Inc., Akos Biosciences, Inc. (“Akos”), and Enveric Therapeutics, Pty. Ltd. (“Enveric Therapeutics”).

     

    Enveric’s lead program, the EVM301 Series, and its lead drug candidate, EB-003, are intended to offer a first-in-class, new approach to the treatment of difficult-to-address mental health disorders, mediated by the promotion of neuroplasticity and without also inducing hallucinations in the patient. Previously, Enveric was developing the EVM201 Series, and its lead drug candidate EB-002 (formerly EB-373), for the treatment of neuropsychiatric disorders. The EVM201 series comprised next generation synthetic prodrugs of the active metabolite, psilocin. In the fourth quarter of 2024, Enveric out-licensed the EVM201 Series program to MycoMedica Life Sciences, who will seek to develop, manufacture, and commercialize EB-002, in exchange for certain development and milestone payments to Enveric. The Company’s primary focus is to develop our lead asset EB-003 in the EVM301 Series.

     

    Reverse Stock Split

     

    The Company effected a 1-for-15 reverse stock split (“Reverse Stock Split”) on January 27, 2025, which began trading on a split-adjusted basis on January 29, 2025, pursuant to which every 15 shares of the Company’s issued and outstanding common stock were reclassified as one share of common stock. The Reverse Stock Split had no impact on the par value of the Company’s common stock or the authorized number of shares of common stock. Unless otherwise indicated, all share and per share information prior to the Reverse Stock Split date of January 29, 2025 in these unaudited condensed consolidated financial statements are retroactively adjusted to reflect the Reverse Stock Split, prior to the rounding of any fractional shares. Any fractional share resulting from the Reverse Stock Split were rounded up to the next whole number of shares, upon which 87,402 roundup shares were issued in January 2025.

     

    Going Concern, Liquidity and Other Uncertainties

     

    The Company has incurred losses since inception resulting in an accumulated deficit of $108,259,471 as of March 31, 2025 and further losses are anticipated in the development of its business. Further, the Company has operating cash outflows of $2,391,582 for the three months ended March 31, 2025. For the three months ended March 31, 2025, the Company had a loss from operations of $2,187,533. Since inception, being a research and development company, the Company has not yet generated revenue and the Company has incurred continuing losses from its operations. The Company’s operations have been funded principally through the issuance of equity. These factors raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the issuance of these unaudited condensed consolidated financial statements.

     

    In assessing the Company’s ability to continue as a going concern, the Company monitors and analyzes its cash and its ability to generate sufficient cash flow in the future to support its operating and capital expenditure commitments. At March 31, 2025, the Company had cash of $4,294,435 and working capital of $3,650,434. The Company’s current cash on hand is not sufficient enough to satisfy its operating cash needs for the 12 months from the filing of this Quarterly Report on Form 10-Q. These conditions raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year after the date the unaudited condensed consolidated financial statements are issued. Management’s plan to alleviate the conditions that raise substantial doubt include raising additional working capital through public or private equity or debt financings or other sources, and may include additional collaborations with third parties as well as disciplined cash spending. Adequate additional financing may not be available to the Company on acceptable terms, or at all. Should the Company be unable to raise sufficient additional capital, the Company may be required to undertake further cost-cutting measures including delaying or discontinuing certain operating activities.

     

    As a result of these factors, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern for a period of one year after the date of the unaudited condensed consolidated financial statements are issued. The Company’s unaudited condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

     

    7

     

     

    ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

    NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

     

    NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

     

    Basis of Presentation and Principal of Consolidation

     

    The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim financial information and Article 8 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by U.S. GAAP for complete financial statements. Management’s opinion is that all adjustments (consisting of normal accruals) considered necessary for a fair presentation have been included. Operating results for the three months ended March 31, 2025 are not necessarily indicative of the results that may be expected for the year ending December 31, 2025. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements for the year ended December 31, 2024, and related notes thereto included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 28, 2025.

     

    The Company’s significant accounting policies and recent accounting standards are summarized in Note 2 of the Company’s consolidated financial statements for the year ended December 31, 2024. There were no significant changes to these accounting policies during the three months ended March 31, 2025.

     

    Use of Estimates

     

    The preparation of the unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amount of assets and liabilities at the date of the financial statements and expenses during the periods reported. By their nature, these estimates are subject to measurement uncertainty and the effects on the financial statements of changes in such estimates in future periods could be significant. Significant areas requiring management’s estimates and assumptions include determining the fair value of transactions involving common stock, the valuation of warrants, the valuation of stock-based compensation and accruals associated with third party providers supporting research and development efforts. Actual results could differ from those estimates.

     

    Reclassification

     

    Certain reclassifications have been made to the prior period’s unaudited condensed consolidated financial statements in order to conform to the current year presentation. In the prior year, the Company included certain consulting expenses within general and administrative expenses on the unaudited condensed consolidated statements of operations. These expenses were reclassified to research and development expenses in the current year. Additionally, the Company has reclassified investment option liability and warrant liability to accrued expenses and other current liabilities on the unaudited condensed consolidated balance sheets and change in fair value of investment option liability and warrant liability to other income on the unaudited condensed consolidated statements of operations in the current year. These reclassifications had no effect on the Company’s previously reported results of operations, changes in equity, or cash flows.

     

    Foreign Currency Translation

     

    From inception through March 31, 2025, the reporting currency of the Company was the United States dollar while the functional currency of certain of the Company’s subsidiaries was the Canadian dollar or the Australian dollar. For the reporting periods ended March 31, 2025 and 2024, the Company engaged in a number of transactions denominated in Canadian dollars and Australian dollars. As a result, the Company is subject to exposure from changes in the exchange rates of the Canadian dollar and Australian dollar against the United States dollar.

     

    The Company translates the assets and liabilities of its Canadian subsidiaries and Australian subsidiary into the United States dollar at the exchange rate in effect on the balance sheet date. Revenues and expenses are translated at the average exchange rate in effect during each monthly period. Unrealized translation gains and losses are recorded as foreign currency translation gain (loss), which is included in the unaudited condensed consolidated statements of shareholders’ equity as a component of accumulated other comprehensive loss.

     

    The Company has not entered into any financial derivative instruments that expose it to material market risk, including any instruments designed to hedge the impact of foreign currency exposures. The Company may, however, hedge such exposure to foreign currency exchange fluctuations in the future.

     

    Adjustments that arise from exchange rate changes on transactions denominated in a currency other than the local currency are included in other comprehensive loss in the unaudited condensed consolidated statements of operations and comprehensive loss as incurred.

     

    8

     

     

    ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

    NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

     

    Concentration of Credit Risk

     

    Financial instruments that potentially subject the Company to concentrations of credit risk consist of cash accounts in a financial institution, which at times, may exceed the federal depository insurance coverage of $250,000 in the United States, AUD$250,000 in Australia and C$100,000 in Canada. The Company has not experienced losses on these accounts, and management believes the Company is not exposed to significant risks on such accounts. As of March 31, 2025, the Company had greater than $250,000 at United States financial institutions, less than AUD$250,000 at Australian financial institutions, and more than C$100,000 at Canadian financial institutions. As of December 31, 2024, the Company had greater than $250,000 at United States financial institutions, less than AUD$250,000 at Australian financial institutions, and less than C$100,000 at Canadian financial institutions.

     

    Income Taxes

     

    The Company files U.S. federal and state returns. The Company’s foreign subsidiary also files a local tax return in their local jurisdiction. From a U.S. federal, state, and Canadian perspective, the years that remain open to examination are consistent with each jurisdiction’s statute of limitations. The Company receives no tax benefit from operating losses due to a full valuation allowance.

     

    Net Loss per Share

     

    Basic net loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted loss per share is computed using the weighted average number of common shares and, if dilutive, potential common shares outstanding during the period. The Company uses the two-class method to determine earnings per share only when the Company is in an income position. Potential common shares consist of the incremental common shares issuable upon the exercise of stock options and warrants (using the treasury stock method). The computation of basic net loss per share for the three months ended March 31, 2025 and 2024 excludes potentially dilutive securities. The computations of net loss per share for each period presented is the same for both basic and fully diluted. In accordance with ASC 260 “Earnings per Share” (“ASC 260”), penny warrants were included in the calculation of weighted average shares outstanding for the purposes of calculating basic and diluted earnings per share. In accordance with ASC 260, 4,541 RSUs that were fully vested on March 31, 2025 were included in basic and dilutive earnings per share as there were no remaining contingencies for these shares to be issued as of March 31, 2025.

     

    Potentially dilutive securities outlined in the table below have been excluded from the computation of diluted net loss per share the three months ended March 31, 2025 and 2024 because the effect of their inclusion would have been anti-dilutive.

     SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES

       2025   2024 
       For the three months ended March 31, 
       2025   2024 
    Warrants to purchase shares of common stock   3,481,267    56,348 
    Restricted stock units - vested and unissued   3,099    3,132 
    Restricted stock units - unvested   41,751    23,742 
    Investment options to purchase shares of common stock   4,667    4,667 
    Options to purchase shares of common stock   1,538    1,723 
    Total potentially dilutive securities   3,532,322    89,612 

     

    Segment Reporting

     

    The Company operates as one operating segment with a focus on developing novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders. The Company’s Chief Executive Officer (“CEO”) as the Chief Operating Decision Maker (“CODM”), manages and allocates resources to the operations of the Company on a consolidated basis. Consolidated loss from operations, which is reported in the accompanying unaudited condensed consolidated statements of operations, is the measure of segment profit or loss that is regularly reviewed by the CODM. This enables the CEO to assess the overall level of available resources and determine how best to deploy these resources across research and development projects in line with the long-term company-wide strategic goals. Refer to the accompanying unaudited condensed consolidated statements of operations for the presentation of consolidated loss from operations for the three months ended March 31, 2025 and 2024. The measure of segment assets is reported in the accompanying unaudited condensed consolidated balance sheets as “Total assets.” There are no significant segment expenses as the expenses that are included in consolidated loss from operations are general and administrative and research and development.

     

    9

     

     

    ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

    NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

     

    NOTE 3. PREPAID EXPENSES AND OTHER CURRENT ASSETS

     

    As of March 31, 2025 and December 31, 2024, the prepaid expenses and other current assets of the Company consisted of the following:

     SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS

       March 31, 2025   December 31, 2024 
    Prepaid insurance  $394,746   $107,610 
    Prepaid other   89,762    152,894 
    Prepaid research and development   55,500    — 
    Prepaid value-added taxes   397    233,054 
    Total prepaid expenses and other current assets  $540,405   $493,558 

     

    NOTE 4. PROPERTY AND EQUIPMENT

     

    Property and equipment consists of the following assets which are located in Calgary, Canada, with all amounts translated into U.S. dollars:

     SCHEDULE OF PROPERTY AND EQUIPMENT NET OF ACCUMULATED DEPRECIATION

       March 31, 2025   December 31, 2024 
    Lab equipment  $769,769   $769,105 
    Computer equipment and leasehold improvements   26,109    26,073 
    Property and equipment, gross   26,109    26,073 
    Less: Accumulated depreciation   (528,599)   (489,401)
    Property and equipment, net of accumulated depreciation  $267,279   $305,777 

     

    Depreciation expense was $38,842 and $43,221 for the three months ended March 31, 2025 and 2024, respectively.

     

    NOTE 5. ACCRUED LIABILITIES

     

    As of March 31, 2025 and December 31, 2024, the accrued liabilities of the Company consisted of the following:

     SCHEDULE OF ACCRUED LIABILITIES

       March 31, 2025   December 31, 2024 
    Product development  $234,614   $332,421 
    Accrued salaries, wages, and bonuses   1,328    1,327 
    Professional fees   152,173    103,968 
    Accrued franchise taxes   7,199    261,100 
    Patent costs   18,000    18,000 
    Other   523    18,282 
    Total accrued liabilities  $413,837   $735,098 

     

    NOTE 6. RELATED PARTY TRANSACTIONS

     

    As of March 31, 2025 and December 31, 2024, there was $101,375 and $232,891, respectively, due to related parties. This balance is related to payments due to board members of the Company. Board member Sheila DeWitt has provided research and development services as an advisory consultant to the Company since May 2022. These services are provided as needed on an hourly basis. During the three months ended March 31, 2025, the Company incurred $3,250 in service fees related to these services. Of these fees, $1,750 has been paid and $1,500 is included in due to related parties on the unaudited condensed consolidated balance sheet as of March 31, 2025. During the three months ended March 31, 2024, the Company incurred $45,500 in service fees related to these services.

     

    10

     

     

    ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

    NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

     

    NOTE 7. SHARE CAPITAL AND OTHER EQUITY INSTRUMENTS

     

    Public Offering

     

    On January 30, 2025, the Company commenced a best efforts public offering (the “Offering”) of an aggregate of (i) 1,229,330 shares (the “Shares”) of Common Stock of the Company, (ii) 437,336 pre-funded warrants (the “Pre-Funded Warrants”) to purchase 437,336 shares of Common Stock (the “Pre-Funded Warrant Shares”), (iii) 1,666,666 Series A warrants (the “Series A Warrants”) to purchase 1,666,666 shares of Common Stock (the “Series A Warrant Shares”), and (iv) 1,666,666 Series B warrants (the “Series B Warrants,” and together with the Series A Warrants, the “Warrants”) to purchase 1,666,666 shares of Common Stock (the “Series B Warrant Shares”). Each Share or Pre-Funded Warrant was sold together with one Series A Warrant to purchase one share of Common Stock and one Series B Warrant to purchase one share of Common Stock. The offering price for each Share and accompanying Warrants was $3.00, and the offering price for each Pre-Funded Warrant and accompanying Warrants was $2.9999. The Pre-Funded Warrants have an exercise price of $0.0001 per share, are exercisable immediately and will expire when exercised in full. Each Warrant has an exercise price of $3.00 per share and will be exercisable immediately upon issuance (“Initial Exercise Date”). The Series A Warrants expire on the five-year anniversary of the Initial Exercise Date. The Series B Warrants expire on the 18-month anniversary of the Initial Exercise Date.

     

    The Offering closed on February 3, 2025. The net proceeds of the Offering, after deducting the fees and expenses of the Placement Agent (as defined below), described in more detail below, and other offering expenses payable by the Company, but excluding the net proceeds, if any, from the exercise of the Warrants, is $4,244,467.

     

    All of the warrants issued in connection with the Offering were determined to be equity classified in accordance with the guidance at ASC 480, Distinguishing Liabilities from Equity and ASC 815-40, Derivatives and Hedging.

     

    In connection with the Offering, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with a certain institutional investor. Pursuant to the Purchase Agreement, the Company agreed not to issue, enter into any agreement to issue or announce the issuance or proposed issuance of any shares of Common Stock or any securities convertible into or exercisable or exchangeable for shares of Common Stock or file any registration statement or prospectus, or any amendment or supplement thereto for 60 days after the closing date of the Offering, subject to certain exceptions. In addition, the Company has agreed not to effect or enter into an agreement to effect any issuance of Common Stock or any securities convertible into or exercisable or exchangeable for shares of Common Stock involving a variable rate transaction (as defined in the Purchase Agreement) until the one-year anniversary of the closing date of the Offering, subject to an exception.

     

    A holder will not have the right to exercise any portion of the Warrants or Pre-Funded Warrants if the holder (together with its affiliates) would beneficially own in excess of 4.99% or 9.99%, as applicable, of the number of shares of Common Stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the Warrants or the Pre-Funded Warrants, respectively.

     

    Pursuant to an engagement agreement, as amended, (the “Engagement Agreement”) with H.C. Wainwright & Co., LLC (the “Placement Agent”), the Company agreed to pay the Placement Agent in connection with the Offering (i) a cash fee equal to 7.0% of the aggregate gross proceeds received in the Offering, (ii) a management fee equal to 1.0% of the aggregate gross proceeds received in the Offering, (iii) a non-accountable expense allowance of $25,000, (iv) reimbursement of up to $100,000 for legal fees and expenses and other out of pocket expenses and (v) up to $15,950 for the clearing expenses.

     

    Also pursuant to the Engagement Agreement, the Company, in connection with the Offering, agreed to issue to the Placement Agent or its designees warrants (the “Placement Agent Warrants”) to purchase up to an aggregate of 116,666 shares of Common Stock (the “Placement Agent Warrant Shares”) (which represents 7.0% of the Shares and Pre-Funded Warrants sold in the Offering). The Placement Agent Warrants have an exercise price of $3.75 per share (which represents 125% of the public offering price per Share and accompanying Warrants), expire on February 3, 2030, and are exercisable following the Initial Exercise Date. The grant date fair value of the Placement Agent Warrants were $147,564 on February 3, 2025 and are were recorded as offering costs. The measurement of fair value of Placement Agent Warrants were determined utilizing a Black-Scholes model considering all relevant assumptions current at the date of issuance (i.e., share price of $1.81, exercise price of $3.75, term of five years, volatility of 106%, risk-free rate of 4.4%, and expected dividend rate of 0%).

     

    As of March 31, 2025, a total of 437,336 shares of Common Stock have been issued due to exercises of the Pre-Funded Warrants and 25,000 shares of Common Stock have been issued due to exercises of Series B Warrants.

     

    11

     

     

    ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

    NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

     

    Stock Options

     

    2020 Long-Term Incentive Plan, as amended (“Incentive Plan”)

     

    Effective March 21, 2025, the Board approved an equitable adjustment to increase the number of shares available under the Incentive Plan by 299,733 shares. As of March 31, 2025, the total number of shares available for grant under the Incentive Plan was 325,392.

     

    The Company’s stock based compensation expense, recorded within general and administrative expense in the unaudited condensed consolidated statement of operations and comprehensive loss, related to stock options for the three months ended March 31, 2025 and 2024 was $414 and $(6,682), respectively.

     

    As of March 31, 2025, the Company had $1,518 in unamortized stock option expense, which will be recognized over a weighted average period of 0.90 years.

     

    Issuance of Restricted Stock Units

     

    The Company’s activity in restricted stock units was as follows for the three months ended March 31, 2025:

     SCHEDULE OF RESTRICTED STOCK UNITS

       Number of shares   Weighted average fair value 
    Non-vested at December 31, 2024   48,017   $24.08 
    Granted   —    — 
    Forfeited   —    — 
    Vested   (6,266)   20.04 
    Non-vested at March 31, 2025   41,751   $24.69 

     

    For the three months ended March 31, 2025 and 2024, the Company recorded $193,434 and $358,170, respectively, in stock-based compensation expense related to restricted stock units, which is a component of both general and administrative and research and development expenses in the unaudited condensed consolidated statement of operations and comprehensive loss. As of March 31, 2025, the Company had unamortized stock-based compensation costs related to restricted stock units of $699,109 which will be recognized over a weighted average period of 1.86 years. As of March 31, 2025, 7,640 restricted stock units are vested without shares of common stock being issued, with all of these shares due as of March 31, 2025.

     

    The following table summarizes the Company’s recognition of stock-based compensation for restricted stock units for the following periods:

     SCHEDULE OF STOCK-BASED COMPENSATION FOR RESTRICTED STOCK UNITS

       2025   2024 
       Three Months Ended March 31, 
       2025   2024 
    Stock-based compensation expense for RSUs:          
    General and administrative  $92,626   $152,429 
    Research and development   100,808    205,741 
    Total  $193,434   $358,170 
    Stock-based compensation expense for RSUs  $193,434   $358,170 

     

    Warrants

     

    The following table summarizes information about shares issuable under warrants outstanding at March 31, 2025:

     SCHEDULE OF WARRANTS OUTSTANDING

       Warrant shares outstanding   Weighted average exercise price   Weighted average remaining life   Intrinsic value 
    Outstanding at December 31, 2024   56,308   $536.70    2.7   $— 
    Issued   3,887,334    2.69    —    — 
    Exercised   (462,336)   0.16    —    — 
    Forfeited   (39)   1,290.00    —    — 
    Outstanding at March 31, 2025   3,481,267    11.63    3.2    — 
                         
    Exercisable at March 31, 2025   3,481,267   $11.63    3.2   $— 

     

    12

     

     

    ENVERIC BIOSCIENCES, INC. AND SUBSIDIARIES

    NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

     

    NOTE 8. LICENSING AGREEMENTS

     

    On July 10, 2024, Akos entered into an Exclusive License Agreement (the “License Agreement”) with Aries Science and Technology, LLC, an Ohio limited liability company (“Aries”), pursuant to which Akos granted Aries a license of Akos’s patented radiation dermatitis topical product. The license allows Akos to use the patented formulation to develop pharmaceutical or non-pharmaceutical products for treating radiation dermatitis suitable for administration to humans or animals. The license is exclusive (subject to certain exceptions contained in the License Agreement), worldwide, royalty-bearing, and includes the right to sublicense. Akos is entitled to potential license payments, milestone payments and royalties based on net revenues of the Licensed Product on a licensed product-by-licensed product and country-by-country basis pursuant to the terms of the Agreement. Aries has the option during the license term, to purchase the rights to each licensed product (on a licensed product-by-licensed product basis) in the form of an exclusive (as to the applicable licensed product), fully paid, transferable right and license to the licensed product.

     

    The Company has not earned any revenue related to this agreement as of March 31, 2025.

     

    On November 7, 2024, the Company entered into an Out-Licensing Agreement (the “Agreement”) with MycoMedica Life Sciences, PBC, a Delaware public benefit corporation (“MycoMedica”), pursuant to which the Company will out-license EB-002 and its EVM201 series to MycoMedica for further development and sales of the product in treatment of neuropsychiatric disorders. MycoMedica will receive an exclusive, global license to the formulations, drugs, method of use, and medical devices developed by Enveric to utilize the compound. As part of the Agreement, the Company received a $20,000 upfront payment in the fourth quarter of 2024, and if certain conditions are met, will receive development and sales milestone payments of up to $62 million and tiered single-digit royalties based on future sales. MycoMedica has the option during the license term to buyout its milestone and royalty payment obligations at a predetermined amount depending upon the stage of product development and commercialization at the time of the buyout. Further, MycoMedica has the right to purchase the licensed patents at a nominal amount upon a change of control of the Company, although doing so does not relieve MycoMedica of any of its payment obligations.

     

    The Company has not earned any revenue related to this agreement during the three months ended March 31, 2025.

     

    On February 3, 2025, Akos entered into two licensing agreements with Restoration Biologics LLC (“Restoration Biologics”), a biotechnology company focused on the treatment of joint disease. The companies have executed two licenses for Akos’ cannabinoid-COX-2 conjugate compounds, for pharmaceutical and potential non-pharmaceutical applications.

     

    The Company has not earned any revenue related to these agreements as of March 31, 2025.

     

    NOTE 9. COMMITMENTS AND CONTINGENCIES

     

    The Company is periodically involved in legal proceedings, legal actions and claims arising in the normal course of business. Management believes that the outcome of such legal proceedings, legal actions and claims will not have a significant adverse effect on the Company’s financial position, results of operations or cash flows.

     

    Other Consulting and Vendor Agreements

     

    The Company has entered into a number of agreements and work orders for future consulting, clinical trial support, and testing services, with terms ranging between one and 12 months. These agreements, in aggregate, commit the Company to approximately $2.8 million in future cash payments.

     

    NOTE 10. SUBSEQUENT EVENTS

     

    The Company entered into an at the market offering agreement, or the (“ATM Agreement”), with H.C. Wainwright & Co., LLC, or (“Wainwright”), acting as sales agent, on April 9, 2025, relating to shares of Common Stock. Under the ATM Agreement, the Company may offer and sell shares of Common Stock having an aggregate offering price of up to $1,854,151 from time to time through Wainwright.

     

    13

     

     

    Item 2. Management’s discussion and analysis of financial condition and results of operations

     

    The information set forth below should be read in conjunction with the unaudited condensed consolidated financial statements and notes thereto included elsewhere in this Quarterly Report on Form 10-Q. Unless stated otherwise, references in this Quarterly Report on Form 10-Q to “us,” “we,” “our,” or our “Company” and similar terms refer to Enveric Biosciences, Inc., a Delaware corporation, and its subsidiaries.

     

    Cautionary Note Regarding Forward-Looking Statements

     

    This Quarterly Report on Form 10-Q (this “Form 10-Q”) contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of forward-looking terms such as “anticipates,” “assumes,” “believes,” “can,” “could,” “estimates,” “expects,” “forecasts,” “guides,” “intends,” “may,” “plans,” “seeks,” “projects,” “targets,” and “would” or the negative of such terms or other variations on such terms or comparable terminology. Such forward-looking statements include, but are not limited to, future financial and operating results, the company’s plans, objectives, expectations and intentions and other statements that are not historical facts. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this Form 10-Q and are subject to a number of risks, uncertainties, and assumptions that could cause actual results to differ materially from our historical experience and our present expectations. These risks and uncertainties include, but are not limited to:

     

    ●our dependence on the success of our prospective product candidates, which are in the early stages of development and may not reach a particular stage in development, receive regulatory approval, or be successfully commercialized;
    ●potential difficulties that may delay, suspend, or scale back our efforts to advance additional early research programs through preclinical development and investigational new drug (“IND”) application filings and into clinical development;
    ●the risk that the cost savings, synergies and growth from our combination with MagicMed Industries Inc. and the successful use of the rights and technologies acquired in the combination may not be fully realized or may take longer to realize than expected;
    ●the limited study on the effects of psychedelic-inspired compounds, and the chance that future clinical research studies may lead to conclusions that dispute or conflict with our understanding and belief regarding the medical benefits, viability, safety, efficacy, dosing, and social acceptance of psychedelic-inspired compounds;
    ●the expensive, time-consuming, and uncertain nature of clinical trials, which are susceptible to change, delays, termination, and differing interpretations;
    ●the ability to establish that potential products are efficacious or safe in preclinical or clinical trials;
    ●the fact that our current and future preclinical and clinical studies may be conducted outside the United States, and the United States Food and Drug Administration may not accept data from such studies to support any new drug applications we may submit after completing the applicable developmental and regulatory prerequisites;
    ●our ability to effectively and efficiently build, maintain and legally protect our molecular derivatives library so that it can be an essential building block from which those in the biotech industry can develop new patented products;
    ●our ability to establish or maintain collaborations on the development of therapeutic candidates;
    ●our ability to obtain appropriate or necessary governmental approvals to market potential products;
    ●our ability to manufacture product candidates on a commercial scale or in collaborations with third parties;
    ●our significant and increasing liquidity needs and potential requirements for additional funding;
    ●our ability to obtain future funding for developing products and working capital and to obtain such funding on commercially reasonable terms;
    ●our ability to continue as a going concern;
    ●legislative changes related to and affecting the healthcare system, including, without limitation, changes and proposed changes to the Patient Protection and Affordable Care Act (“PPACA”);
    ●the intense competition we face, often from companies with greater resources and experience than us;
    ●our ability to retain key executives and scientists;
    ●the ability to secure and enforce legal rights related to our products, including intellectual property rights and patent protection;
    ●political, economic, and military instability in Israel which may impede our development programs;
    ●adverse macroeconomic conditions; geopolitical tensions; laws and policies resulting from federal and state governments in the United States and Canada; impact of American trade tariffs and retaliatory tariffs by other nations;
    ●the impact of tariffs and other trade protective measures (including tariffs that have been or may in the future be imposed by the United States or other countries); and
    ●our success at managing the risks involved in the foregoing.

     

    For a more detailed discussion of these and other factors that may affect our business and that could cause the actual results to differ materially from those projected in these forward-looking statements, see the risk factors and uncertainties set forth in Part II, Item 1A of this Form 10-Q and Part I, Item 1A of the Annual Report on Form 10-K for the year ended December 31, 2024. Any one or more of these uncertainties, risks and other influences could materially affect our results of operations and whether forward-looking statements made by us ultimately prove to be accurate. We undertake no obligation to publicly update or revise any forward-looking statements, whether from new information, future events or otherwise, except as required by law.

     

    14

     

     

    Business Overview

     

    We are a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, addiction, and other psychiatric disorders. Leveraging our unique discovery and development platform, the Psybrary™, which houses proprietary information on the use and development of existing and novel molecules for specific mental health indications, Enveric seeks to develop a robust intellectual property portfolio of novel drug candidates.

     

    Enveric’s lead program, the EVM301 Series, and its lead drug candidate, EB-003, are intended to offer a first-in-class, new approach to the treatment of difficult-to-address mental health disorders, mediated by the promotion of neuroplasticity and without also inducing hallucinations in the patient. Enveric unveiled its EVM401 Series on February 25, 2025, which is intended to broaden Enveric’s pipeline with additional non-hallucinogenic molecules and strengthen its ability to target addiction and neuropsychiatric disorders for patients with limited options. Previously, Enveric was developing the EVM201 Series, and its drug candidate EB-002 (formerly EB-373), for the treatment of neuropsychiatric disorders. The EVM201 Series comprised next generation synthetic prodrugs of the active metabolite, psilocin. In the fourth quarter of 2024, Enveric out-licensed the EVM201 Series program to MycoMedica Life Sciences, who will seek to develop, manufacture, and commercialize EB-002, in exchange for certain development and milestone payments to Enveric (discussed below).

     

    Neuroplastogens

     

    Following our amalgamation with MagicMed in September 2021, we have continued to pursue the development of MagicMed’s proprietary library, the Psybrary™, which we believe will help us to identify and develop the right drug candidates needed to address mental health challenges, including depression, anxiety, and addiction disorders. We synthesize novel phenylalkylamines and indolethylamines, using a mixture of chemistry and synthetic biology, resulting in the expansion of the Psybrary™, which currently includes 20 patent families with claims covering a million potential molecular structures, over one thousand of which we have so far synthesized in sufficient quantities to identify and hundreds of which we have screened for receptor binding and other relevant activities.

     

    The Company developed certain intellectual property rights around the trademark PsyAI™ for potential use. On March 6, 2025, Enveric announced it is soliciting Requests-For Proposals (“RFPs”) for the license or sale of its PsyAI™ trademark portfolio as a means of maximizing value for an asset which is no longer strategic given the Company’s focus on drug development. This limited portfolio of US and Canadian trademark assets is held by its subsidiary, Enveric Biosciences Canada, Inc. Enveric expects the period for RFPs to remain open until August 31, 2025, with a decision to follow within three (3) months thereafter.

     

    At this stage, we have entered into several non-binding term sheets with strategic partners to out-license certain molecules from the Psybrary™. Going forward, in order to build a pipeline of product candidates, we intend to both continue to internally develop new drug candidates with associated intellectual property and to acquire, through in-licensing, additional intellectual property from pharmaceutical and biotechnology companies and research institutions. The in-licensed assets could include both research stage and clinical stage drug candidates.

     

    15

     

     

    While we intend to pursue development of the EVM401 Series, our primary focus is to develop our lead asset EB-003 in the EVM301 Series. The development status of the product is shown in the table below:

     

    Product Candidates   Targeted Indications   Status   Expected Next Steps
    EB-003   Mental health indication   Preclinical Development   IND Filing
    Psychedelic-inspired drug candidate            

     

    Recent Developments

     

    Reverse Stock Split

     

    We effected a 1-for-15 reverse stock split on January 27, 2025, which began trading on a split-adjusted basis on January 29, 2025, pursuant to which every 15 shares of our issued and outstanding common stock were reclassified as one share of common stock. No fractional shares were issued as a result of the reverse stock split. Any fractional shares that were to otherwise have resulted from the reverse stock split were rounded up to the next whole number. The reverse stock split had no impact on the par value of our common stock or the authorized number of shares of our common stock.

     

    January 2025 Offering

     

    On January 30, 2025, the Company commenced a best efforts public offering (the “Offering”) of an aggregate of (i) 1,229,330 shares (the “Shares”) of common stock of the Company, (ii) 437,336 pre-funded warrants (the “Pre-Funded Warrants”) to purchase 437,336 shares of common stock (the “Pre-Funded Warrant Shares”), (iii) 1,666,666 Series A warrants (the “Series A Warrants”) to purchase 1,666,666 shares of common stock (the “Series A Warrant Shares”), and (iv) 1,666,666 Series B warrants (the “Series B Warrants,” and together with the Series A Warrants, the “Warrants”) to purchase 1,666,666 shares of common stock (the “Series B Warrant Shares”). Each Share or Pre-Funded Warrant was sold together with one Series A Warrant to purchase one share of common stock and one Series B Warrant to purchase one share of common stock. The offering price for each Share and accompanying Warrants was $3.00, and the offering price for each Pre-Funded Warrant and accompanying Warrants was $2.9999. The Pre-Funded Warrants have an exercise price of $0.0001 per share, are exercisable immediately and will expire when exercised in full. Each Warrant has an exercise price of $3.00 per share and will be exercisable immediately upon issuance (“Initial Exercise Date”). The Series A Warrants expire on the five-year anniversary of the Initial Exercise Date. The Series B Warrants expire on the 18-month anniversary of the Initial Exercise Date.

     

    The Offering closed on February 3, 2025. The net proceeds of the Offering, after deducting the fees and expenses of the Placement Agent (as defined below) and other offering expenses payable by the Company, but excluding the net proceeds, if any, from the exercise of the Warrants, is approximately $4.2 million. The Company intends to use the net proceeds from the Offering for working capital, EB-003 development, and general corporate purposes.

     

    Results of Operations

     

    The following table sets forth information comparing the components of net loss for the three months ended March 31, 2025 and 2024:

     

       For the Three Months Ended March 31, 
       2025   2024 
    Operating expenses          
    General and administrative  $1,360,138   $1,885,753 
    Research and development   746,371    506,155 
    Depreciation and amortization   81,024    85,409 
    Total operating expenses   2,187,533    2,477,317 
               
    Loss from operations   (2,187,533)   (2,477,317)
               
    Other income          
    Other income   2,565    21,437 
    Interest income, net   2    696 
    Total other income   2,567    22,133 
               
    Net loss before income taxes  $(2,184,966)  $(2,455,184)
               
    Income tax expense   —    (1,731)
               
    Net loss  $(2,184,966)  $(2,456,915)

     

    16

     

     

    General and Administrative Expenses

     

    Our general and administrative expenses decreased to $1,360,138 for the three months ended March 31, 2025 from $1,885,753 for the three months ended March 31, 2024, a decrease of $525,615, or 28%. This change was primarily driven by decreases in director fees of $147,000, accounting fees of $68,954, legal fees of $48,852, salaries and wages of $56,360, stock compensation expense of $52,703, insurance expenses of $25,994, audit fees of $23,845, software expense of $21,234, and public company fees of $43,458.

     

    Research and Development Expenses

     

    Our research and development expense for the three months ended March 31, 2025 was $746,371 as compared to $506,155 for the three months ended March 31, 2024 with an increase of $240,216, or approximately 47%. This increase was primarily driven by an increase in consulting fees of $305,032 and a prior year gain that was realized during the three months ended March 31, 2024 related to the Australian R&D tax incentive of $399,987, offset by decreases in CRO costs of $398,744, salaries and wages of $147,725 and rent expense of $28,577.

     

    Depreciation and Amortization Expense

     

    Depreciation and amortization expense for the three months ended March 31, 2025 was $81,024 as compared to $85,409 for the three months ended March 31, 2024, with a decrease of $4,385, or approximately 5%.

     

    Going Concern, Liquidity and Capital Resources

     

    The Company has incurred losses since inception resulting in an accumulated deficit of $108,259,471 as of March 31, 2025 and further losses are anticipated in the development of its business. For the three months ended March 31, 2025, the Company had a loss from operations of $2,187,533. Further, the Company had operating cash outflows of $2,391,582 for the three months ended March 31, 2025. Since inception, being a research and development company, the Company has not generated revenue and the Company has incurred continuing losses from its operations. The Company’s operations have been funded principally through the issuance of debt and equity. These factors raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the issuance of these unaudited condensed consolidated financial statements.

     

    In assessing the Company’s ability to continue as a going concern, the Company monitors and analyzes its cash and its ability to generate sufficient cash flow in the future to support its operating and capital expenditure commitments. At March 31, 2025, the Company had cash of $4,294,435 and working capital of $3,650,434. The Company’s current cash on hand is insufficient to satisfy its operating cash needs for the 12 months following the filing of this Quarterly Report on Form 10-Q. These conditions raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year after the date the financial statements are issued. Management’s plan to alleviate the conditions that raise substantial doubt include raising additional working capital through public or private equity or debt financings or other sources, and may include additional collaborations with third parties as well as disciplined cash spending. For example, the Company recently entered into an agreement with H.C. Wainwright & Co., LLC to conduct an “at-the-market” offering, whereby the Company may offer and sell shares of its common stock for an aggregate offering price of up to $1.8 million. Adequate additional financing may not be available to us on acceptable terms, or at all. Should the Company be unable to raise sufficient additional capital, the Company may be required to undertake cost-cutting measures including delaying or discontinuing certain operating activities.

     

    As a result of these factors, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern for a period of one year after the date of the financial statements. The Company’s unaudited condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

     

    17

     

     

    Cash Flows

     

    Since inception, we have primarily used our available cash to fund our product development and operations expenditures.

     

    Cash Flows for the Three Months Ended March 31, 2025 and 2024

     

    The following table sets forth a summary of cash flows for the years presented:

     

       For the Three Months Ended March 31, 
       2025   2024 
    Net cash used in operating activities  $(2,391,582)  $(2,598,347)
    Net cash provided by financing activities   4,448,914    6,658,269 
    Effect of foreign exchange rate on changes on cash   (3,923)   8,137 
    Net increase in cash  $2,053,409   $4,068,059 

     

    Operating Activities

     

    Net cash used in operating activities was $2,391,582 during the three months ended March 31, 2025, which consisted primarily of a net loss adjusted for non-cash items of $1,912,659, an increase in prepaid expenses of $46,126, a decrease in related party expenses of $131,516 and a decrease in accounts payable and accrued liabilities of $301,281.

     

    Net cash used in operating activities was $2,598,347 during the three months ended March 31, 2024, which consisted primarily of a net loss adjusted for non-cash items of $2,041,455, an increase in prepaid expenses and other current assets of $759,289, offset by an increase in accounts payable and accrued liabilities of $202,397.

     

    Financing Activities

     

    Net cash provided by financing activities was $4,448,914 during the three months ended March 31, 2025, which consisted of $4,373,870 in proceeds from the Offering, and $75,044 in proceeds from the exercise of warrants.

     

    Net cash provided by financing activities was $6,658,269 during the three months ended March 31, 2024, which consisted of $1,817,640 from the proceeds received from the stock subscription receivable, $2,676,980 for the exercise of the inducement warrants, and $2,307,707 for the common stock sold under a distribution agreement, net of offering costs, and offset by $144,058 offering costs previously accrued for the inducement warrants.

     

    Critical Accounting Estimates

     

    Our unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP, which requires us to make estimates, assumptions and judgments that affect the reported amount of assets, liabilities, costs and expenses and related disclosures. Our critical accounting estimates are those estimates that involve a significant level of uncertainty at the time the estimate was made, and changes in them have had or are reasonably likely to have a material effect on our financial condition or results of operations. Accordingly, actual results could differ materially from our estimates. We base our estimates on past experience and other assumptions that we believe are reasonable under the circumstances, and we evaluate these estimates on an ongoing basis. Our most critical accounting estimate includes determining the accruals associated with third party providers supporting research and development efforts.

     

    There have been no material changes to our critical accounting estimates as compared to the critical accounting estimates disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024.

     

    18

     

     

    Item 3. Quantitative and Qualitative Disclosures About Market Risk

     

    Our primary market risk exposure is foreign currency exchange rate risk. From inception through March 31, 2025, the Company’s reporting currency is the United States dollar while the functional currency of certain of the Company’s subsidiaries were the Canadian dollar and Australian dollar. For the reporting periods ended March 31, 2025 and March 31, 2024, the Company engaged in a number of transactions denominated in Canadian dollars and Australian dollars. As a result, the Company is subject to exposure from changes in the exchange rates of the Canadian dollar and Australian dollar against the U.S. dollar.

     

    The Company has not entered into any financial derivative instruments that expose it to material market risk, including any instruments designed to hedge the impact of foreign currency exposures. The Company may, however, hedge such exposure to foreign currency exchange fluctuations in the future.

     

    Item 4. Controls and Procedures

     

    Evaluation of Disclosure Controls and Procedures

     

    We maintain disclosure controls and procedures designed to ensure that the information we are required to disclose in reports we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified under the rules and forms of the SEC. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that such information is accumulated and communicated to our management, including our Chief Executive Officer and our Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosures.

     

    As required by paragraph (b) of Rules 13a-15 and 15d-15 under the Exchange Act, our Chief Executive Officer (our principal executive) and Chief Financial Officer (our principal financial officer and principal accounting officer) carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as of March 31, 2025. Based on this evaluation, and in light of the material weaknesses found in our internal controls over financial reporting as of December 31, 2024, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures (as defined in paragraph (e) of Rules 13a-15 and 15d-15 under the Exchange Act) were not effective as of March 31, 2025.

     

    Management’s Remediation Plan

     

    As previously discussed in our Annual Report on Form 10-K for the year ended December 31, 2024, management had concluded that our internal control over financial reporting was not effective as of December 31, 2024, because management identified inadequate segregation of duties to ensure the processing, review, and authorization of all transactions, including non-routine transactions resulting in deficiencies, which, in aggregate, amounted to a material weakness in the Company’s internal control over financial reporting.

     

    Management has taken, and is taking steps to strengthen our internal control over financial reporting: we have conducted evaluation of the material weakness to determine the appropriate remedy and have established procedures for documenting disclosures and disclosure controls.

     

    While we have taken certain actions to address the material weaknesses identified, additional measures may be necessary as we work to improve the overall effectiveness of our internal controls over financial reporting.

     

    Changes in Internal Control over Financial Reporting

     

    Other than the changes being undertaken as part of the Company’s remediation plan, there have been no other changes in our internal controls over financial reporting (as defined in Rule 13a-15(f) and 15d-(f) of the Exchange Act) that occurred during quarter ending March 31, 2025, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

     

    19

     

     

    PART II. OTHER INFORMATION

     

    Item 1. Legal proceedings

     

    The Company may periodically be involved in legal proceedings, legal actions and claims arising in the ordinary course of business. In the opinion of management, we do not have any pending litigation that, separately or in the aggregate, have a material adverse effect on our financial position, results of operations or cash flows.

     

    Item 1A. Risk factors

     

    Factors that could cause our actual results to differ materially from those in this Quarterly Report are any of the risks described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 as filed with the SEC on March 28, 2025. Any of these factors could result in a significant or material adverse effect on our results of operations of financial condition. Additional risk factors not presently known to us or that we currently deem immaterial may also impair our business or results of operations. As of the date of this Quarterly Report, other than as described below, there have been no material changes to the risk factors disclosed in the Company’s Annual Report.

     

    Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

     

    None.

     

    Item 3. Defaults Upon Senior Securities

     

    None.

     

    Item 4. Mine Safety Disclosures

     

    Not applicable.

     

    Item 5. Other Information

     

    None.

     

    Item 6. Exhibits

     

    Exhibit No.   Description
         
    4.1   Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.14 of the Company’s Registration Statement on Form S-1/A, filed with the Commission on January 30, 2025)
    4.2   Form of Series A Warrant (incorporated by reference to Exhibit 4.15 of the Company’s Registration Statement on Form S-1/A, filed with the Commission on January 30, 2025)
    4.3   Form of Series B Warrant (incorporated by reference to Exhibit 4.16 of the Company’s Registration Statement on Form S-1/A, filed with the Commission on January 30, 2025)
    4.4   Form of Placement Agent Warrants (incorporated by reference to Exhibit 4.17 of the Company’s Registration Statement on Form S-1/A, filed with the Commission on January 30, 2025)
    10.1   Form of Securities Purchase Agreement (incorporated by reference to Exhibit 10.33 of the Company’s Registration Statement on Form S-1/A, filed with the Commission on January 30, 2025)
    31.1   Certification pursuant to Section 302 of the Sarbanes–Oxley Act of 2002 of Principal Executive Officer*
    31.2   Certification pursuant to Section 302 of the Sarbanes–Oxley Act of 2002 of Principal Financial and Accounting Officer*
    32   Certification pursuant to Section 906 of the Sarbanes–Oxley Act of 2002 of Principal Executive Officer, Principal Financial and Accounting Officer**
    101.INS   Inline XBRL Instance Document*
    101.SCH   Inline XBRL Taxonomy Extension Schema*
    101.CAL   Inline XBRL Taxonomy Extension Calculation Linkbase Document*
    101.DEF   Inline XBRL Taxonomy Extension Definition Linkbase Document*
    101.LAB   Inline XBRL Taxonomy Extension Labels Linkbase Document*
    101.PRE   Inline XBRL Taxonomy Extension Presentation Linkbase Document*
    104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

     

    *   Filed herewith.
    **   Furnished herewith.

     

    20

     

     

    SIGNATURES

     

    Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, on May 14, 2025.

     

      Enveric Biosciences, Inc.
         
      By: /s/ Joseph Tucker
      Name: Joseph Tucker, Ph.D.
      Title: Chief Executive Officer
        (Principal Executive Officer)
         
      By: /s/ Kevin Coveney
      Name: Kevin Coveney
      Title: Chief Financial Officer
        (Principal Financial and Accounting Officer)

     

    21

     

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      The proposed spin-off would create two separate and distinct biotechnology companies, one developing next-generation psychedelic-inspired treatments and the other developing innovative cannabinoid treatments Enveric Biosciences (NASDAQ:ENVB) ("Enveric" or the "Company"), a biotechnology company dedicated to the development of novel small-molecule therapeutics for the treatment of anxiety, depression and addiction disorders, today announced the confidential submission of a Form S-1 draft registration statement with the U.S. Securities and Exchange Commission (‘SEC') for the spin-off its cannabinoid clinical development pipeline to a wholly-owned subsidiary, Akos Biosciences, Inc. (‘Akos'),

      11/28/22 7:30:00 AM ET
      $ENVB
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $ENVB
    Insider Trading

    Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

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    • CHIEF INNOVATION OFFICER Facchini Peter J. was granted 24,717 shares, increasing direct ownership by 296% to 33,058 units (SEC Form 4)

      4 - Enveric Biosciences, Inc. (0000890821) (Issuer)

      5/12/25 5:00:16 PM ET
      $ENVB
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • CHIEF FINANCIAL OFFICER Coveney Kevin Michael was granted 74,150 shares, increasing direct ownership by 596% to 86,584 units (SEC Form 4)

      4 - Enveric Biosciences, Inc. (0000890821) (Issuer)

      5/12/25 5:00:20 PM ET
      $ENVB
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • CHIEF EXECUTIVE OFFICER Tucker Joseph Edward was granted 98,866 shares, increasing direct ownership by 453% to 120,711 units (SEC Form 4)

      4 - Enveric Biosciences, Inc. (0000890821) (Issuer)

      5/12/25 5:00:06 PM ET
      $ENVB
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $ENVB
    Insider Purchases

    Insider purchases reveal critical bullish sentiment about the company from key stakeholders. See them live in this feed.

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    • SEC Form 4: Pasqualone Frank bought $2,140 worth of shares (1,000 units at $2.14)

      4 - Enveric Biosciences, Inc. (0000890821) (Issuer)

      9/19/23 5:34:00 PM ET
      $ENVB
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $ENVB
    Analyst Ratings

    Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.

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    • Enveric Biosciences downgraded by Aegis Capital with a new price target

      Aegis Capital downgraded Enveric Biosciences from Buy to Hold and set a new price target of $0.20 from $7.00 previously

      3/8/22 9:32:53 AM ET
      $ENVB
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Aegis Capital initiated coverage on Enveric Biosciences with a new price target

      Aegis Capital initiated coverage of Enveric Biosciences with a rating of Buy and set a new price target of $7.00

      7/8/21 9:31:19 AM ET
      $ENVB
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Maxim Group initiated coverage on Enveric Biosciences with a new price target

      Maxim Group initiated coverage of Enveric Biosciences with a rating of Buy and set a new price target of $6.00

      6/28/21 8:59:11 AM ET
      $ENVB
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $ENVB
    SEC Filings

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    • SEC Form 10-Q filed by Enveric Biosciences Inc.

      10-Q - Enveric Biosciences, Inc. (0000890821) (Filer)

      5/14/25 4:59:36 PM ET
      $ENVB
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Enveric Biosciences Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Financial Statements and Exhibits

      8-K - Enveric Biosciences, Inc. (0000890821) (Filer)

      5/14/25 4:15:30 PM ET
      $ENVB
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form EFFECT filed by Enveric Biosciences Inc.

      EFFECT - Enveric Biosciences, Inc. (0000890821) (Filer)

      4/18/25 12:15:08 AM ET
      $ENVB
      Biotechnology: Pharmaceutical Preparations
      Health Care